FDA Medical Device Recalls (openFDA)
Safe N Simple, LLC: DermaPro Waterproof Silicone Tape, SNS57232
- Recall number
- Z-2229-2018
- Recalling firm
- Safe N Simple, LLC
- Product
- DermaPro Waterproof Silicone Tape, SNS57232
- Status
- Terminated
- Initiated
- 2017-12-14
- Posted
- not on file
- Terminated
- 2019-04-04
- Reason
- The recalling firm received a customer complaint stating the tape was difficult to peel off the roll and had poor adhesion.
- Root cause
- Process control
- Action
- The recalling firm notified its distributors via phone call and email on January 3, 2018. The firm informed distributors of the issue with the affected product, and offered to replace affected product, and suggested replacing product distributed to customers.
- Quantity
- 318 rolls
- Distribution
- Distributors in two states: AL and OH.
- Lot, serial or model codes
- 20170716.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KGX
- Firm FEI
- 3008374791
- Firm city
- Clarkston
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28